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A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population (STEP Study)

Sponsor
California Institute of Renal Research (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04633304
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
12.5
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an investigator-initiated post-marketing study that will evaluate use of the WaveLinQ system, a new and novel method of fistula creation using a percutaneous method in patients who require the creation of an arteriovenous fistula (AVF).

Condition or Disease Intervention/Treatment Phase
  • Device: EndoAVF System for endovascular AV fistula creation
 N/A

Detailed Description

This investigator-initiated post-marketing study will evaluate use of the WaveLinQ system, a new and novel method of fistula creation, which uses a percutaneous method to create an AVF. Thirty male and female subjects with CKD 3-5 and who are clinical indicated for arteriovenous fistula (AVF) creation will be enrolled using the WaveLinQ device. Eligibility confirmation will be confirmed during screening up to 28 days from the index procedure. Subjects who are eligible will undergo fistula creation per standard institutional technique (index/baseline) and be followed at least monthly for 6 months per their standard of care plan. Primary, clinical and functional patency will be observed throughout the trial in addition to other data collection points per protocol. The expected total duration of subject participation from screening until the end of study is up to 7 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
primary end pointprimary end point
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population
Anticipated Study Start Date :
Dec 15, 2020
Anticipated Primary Completion Date :
Dec 15, 2020
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: AVF

Single arm study using primary and secondary end points as comperators between subjects.

Device: EndoAVF System for endovascular AV fistula creation
AV fistula creation
Other Names:
  • WavelinQ™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Procedure Success [Interval of time from access placement until any intervention is undertaken to maintain or re-establish patency - 6 weeks]

      Successful endoAVF creation confirmed by intraprocedural angiography or duplex Ultrasound post procedure

    Secondary Outcome Measures

    1. Physiologically mature endoAVF at 6 months [6 months]

      Percent of patients who did not require any intervention to be undertaken to maintain or re-establish patency

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or Female Age of at least 18 years

    2. CKD 3 through 5 as measured by GFR 45 and under by MDRD equation on two separate occasions at least 3 months apart.

    3. Provide written informed consent using a form that is approved by the Institutional Review Board (IRB) prior to collection of study data or performance of study procedures.

    4. Currently not on hemodialysis.

    5. Life expectancy of at least one year

    6. Meets Anatomical Criteria for EndoAVF creation via pre-procedure Duplex or Venography Vascular anatomy suitable for creation of the AV fistula

    7. Willing to comply with the specified follow-up evaluations

    Exclusion Criteria:

    1. Anatomical exclusion criteria met

    2. Thought to need dialysis within 30 days.

    3. The subject is in a hypercoagulable state.

    4. The subject has known bleeding diathesis.

    5. The subject has insufficient cardiac output to support a native fistula in the opinion of the investigator.

    6. Known history of active intravenous drug abuse.

    7. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.

    8. The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.

    9. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 California Institute of Renal Research Escondido California United States 92027

    Sponsors and Collaborators

    • California Institute of Renal Research

    Investigators

    • Principal Investigator: Osman Khawar, MD, California Institute of Renal Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    California Institute of Renal Research
    ClinicalTrials.gov Identifier:
    NCT04633304
    Other Study ID Numbers:
    • STP-001
    First Posted:
    Nov 18, 2020
    Last Update Posted:
    Nov 18, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by California Institute of Renal Research
    CKD

    Study Results

    No Results Posted as of Nov 18, 2020